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510(k) K981165

AIMSTEP COMBO PREGNANCY, 1 TEST, 30 TEST, 50 TEST, 100 TEST by Germaine Laboratories, Inc. — Product Code JHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 1998
Date Received
March 31, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Visual, Pregnancy Hcg, Prescription Use
Device Class
Class II
Regulation Number
862.1155
Review Panel
CH
Submission Type

Other clearances by Germaine Laboratories, Inc.

  • K051727 — AIMSTICK URINE REAGENT STRIPS (October 26, 2005)
  • K013857 — AIMSTEP PREGNANCY (January 22, 2002)
  • K991369 — ACCUDIP HOME PREGNANCY AND/OR AIMSTICK PREGNANCY (May 10, 1999)
  • K980531 — AIMSTEP PREGNANCY (March 6, 1998)
  • K974512 — AIMSTICK PBD COMBO PREGNANCY (January 2, 1998)
  • K974368 — AIMSTICK PBD PREGNANCY (January 2, 1998)
  • K973825 — MIDSTREAM HOME REGNANCY TEST (December 19, 1997)

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